Long-term Efficacy of Biosimilar CT-P16 Matches European-Approved Bevacizumab in Non-Small Cell Lung Cancer

Strategic Insights -

A new study published in the Cancer Treatment and Research Communications journal has found that a biosimilar version of bevacizumab, known as CT-P16, has equivalent long-term efficacy to the European-approved reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). Researchers at the Clinical Hospital Center in Belgrade, Serbia conducted the phase 3 trial, which involved 689 patients who received either CT-P16 or EU-bevacizumab in combination with paclitaxel and carboplatin during induction treatment. The study found that the objective response rates for CT-P16 and EU-bevacizumab were 45.6% and 46.1%, respectively, with similar response durations, time to progression, progression-free survival, and overall survival.

Key Takeaways:

  • The study involved 689 patients with metastatic or recurrent non-squamous NSCLC, who received either CT-P16 or EU-bevacizumab in combination with paclitaxel and carboplatin during induction treatment.
  • The objective response rate for CT-P16 was 45.6% (95% CI: 40.34-50.89), while the objective response rate for EU-bevacizumab was 46.1% (95% CI: 40.86-51.35).
  • Response duration, time to progression, progression-free survival, and overall survival were similar between the two groups.
  • The study found no new safety signals, and the long-term results confirm the equivalent efficacy of CT-P16 and EU-bevacizumab in patients with metastatic or recurrent non-squamous NSCLC.
  • The study suggests that biosimilars could be a cost-effective and accessible alternative to reference medicines, while maintaining the same level of efficacy.
  • The study was funded by Celltrion Pharm Inc. and involved researchers from the Clinical Hospital Center, Belgrade, Serbia, and other institutions.
  • The study concluded that the long-term results of the CT-P16 3.1 study confirm the equivalent efficacy of CT-P16 and EU-bevacizumab in patients with metastatic or recurrent non-squamous NSCLC.

Statistics:

  • The study involved 689 patients with metastatic or recurrent non-squamous NSCLC.
  • 72.4% of patients completed the induction period, 67.6% initiated the maintenance period, and 56.5% entered follow-up.
  • The objective response rates for CT-P16 and EU-bevacizumab were 45.6% and 46.1%, respectively.
  • Response duration, time to progression, progression-free survival, and overall survival were similar between the two groups.

Sources:

  • Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer. Cancer Treatment and Research Communications, 2025,44():100970.
  • Clinical Hospital Center, Belgrade, Serbia.
  • Celltrion Pharm Inc.